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    Summary
    EudraCT Number:2011-005037-39
    Sponsor's Protocol Code Number:KEKLUKACS-CLIN-01
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-02-03
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-005037-39
    A.3Full title of the trial
    A Phase II Randomized, Controlled Parallel-Group Pilot Study to Assess the Safety and Efficacy of Kék Lukács Ointment Compared to Standard Silver Sulphadiazine (Dermazin®, SSD) Therapy in the Wound-healing of Patients With Deep Partial Thickness (Second-Degree) Burns
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial to Assess the Safety and Efficacy of Kék Lukács Ointment in Treating Wound-healing of Patients With Deep Partial Thickness Burns
    A.3.2Name or abbreviated title of the trial where available
    Clinical Trial of Kék Lukács Ointment in Treating Wounds
    A.4.1Sponsor's protocol code numberKEKLUKACS-CLIN-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLukács és Társa Gyógyszerkereskedelmi Betéti Társaság
    B.1.3.4CountryHungary
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLukács és Társa Gyógyszerkereskedelmi Betéti Társaság
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAdWare Research Ltd.‎
    B.5.2Functional name of contact pointKÉKLUKÁCS Help Desk
    B.5.3 Address:
    B.5.3.1Street AddressVölgy utca 41.
    B.5.3.2Town/ cityBalatonfüred
    B.5.3.3Post code8230
    B.5.3.4CountryHungary
    B.5.4Telephone number3687789073
    B.5.5Fax number3687789074
    B.5.6E-mailinfo@adwareresearch.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameKék Lukács Ointment
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZITHROMYCIN
    D.3.9.1CAS number 83905-01-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSULFAMETHOXAZOLE
    D.3.9.1CAS number 723-46-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number28
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMICONAZOLE
    D.3.9.1CAS number 22916-47-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Dermazin®
    D.2.1.1.2Name of the Marketing Authorisation holderLEK Pharmaceuticals d.d.
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDermazin®
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSULFADIAZINE SILVER
    D.3.9.1CAS number 22199-08-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with burn injuries confined to the trunk and/or upper and lower extremities. Total burn area for all burns on a single patient should be no greater than 15% of TBSA. Patients’ total study target burn area (deep second-degree) should be greater than 50 cm2 but no greater than 200 cm2 (or 1% of TBSA).
    E.1.1.1Medical condition in easily understood language
    Patients with burn injuries confined to the trunk and/or upper and lower extremities.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the clinical efficacy of Kék Lukács ointment treatment with standard silver sulphadiazine (SSD) therapy in wound healing; degree of epithelisation of wound until Day 22 of treatment compared to Day 1.
    E.2.2Secondary objectives of the trial
    1. Investigator‘s assessment of signs of wound infection and inflammation.
    2. Assess the wound bed and wound margin.
    3. Compare the effect of Kék Lukács ointment treatment and SSD therapy on bacterial load.
    4. Assess the degree of epithelisation of wound.
    5. Assess the tolerability of local therapy of target wound based on sensitivity and local irritability on every day during treatment.
    6. Evaluate the satisfaction of cosmetic result: general wound appearance and effect on crusting and scabbing after Kék Lukács ointment treatment comparing to SSD treatment.
    7. Reach eligibility to skin transplantation if needed.
    8. Assess the ease of application of Kék Lukács ointment; evaluating pain at application and at dressing changes at every visit.
    9. Pharmacokinetic analysis will be performed of Kék Lukács treated patients to assess the plasma levels of sulfamethoxazole, azithromycin, and miconazole.
    10. Collect pharmacoeconomic information.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent by the patient
    2. Male and female patients aged between 18 and 65 years
    3. Female patients with childbearing potential with a negative result from pregnancy test at inclusion, who agrees to use an acceptable birth control method (hormonal or IUD) or abstinence throughout the trial
    4. Thermal origin burns
    5. Total burn area for all burns on a single patient should be no greater than 15% of TBSA
    6. Patients with burn injuries confined to the trunk and/or upper and lower extremities
    7. Patients’ total study target burn area (second-degree) should be greater than
    50 cm2 but no greater than 200 cm2 (or 1% of TBSA).
    8. Patients with fresh (burn therapy started less than 24 hours post burn) second-degree burns (deep or mixed deep and superficial partial thickness burns).
    9. Patients with non recent second-degree burns (burn therapy started later than 24 but not later than 36 hours post-burn).
    10. Able to communicate well with the investigator and comply with the study requirements
    E.4Principal exclusion criteria
    1. Patients with significant co-morbid conditions like chronic respiratory illness, ischemic or other cardiac disease and/or diabetes, immunodeficiency.
    2. Patients with inhalation injury.
    3. Burns >15% TBSA.
    4. Patients with known or suspected allergy to any of the components of Kék Lukács ointment or SSD cream.
    5. Head, genitalia, palms of hands, soles of feet and face are excluded as test sites.
    6. Circumferential burns
    7. Electrical and/or chemical burns.
    8. Clinically significant systemic infections requiring systematic antibiotic treatment.
    9. Patients with vascular or skin disorders that directly affect the designated wound site.
    10. Any other acute or chronic concurrent medical conditions that in the Investigator’s opinion compromise study participation.
    11. Lactation, pregnancy or women of childbearing potential not practicing an adequate method of contraception.
    12. Participation in a clinical trial within 30 days before start of the trial.
    13. History of drug and/or alcohol abuse.
    E.5 End points
    E.5.1Primary end point(s)
    Percent of reduction in wound surface area from Day 1 to Day 22 (3 weeks after treatment start).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 22
    E.5.2Secondary end point(s)
    1. Incidence of complete wound healing full epithelisation within 22 days.
    2. Time to complete wound healing if full epithelisation occurs within 22 days.
    3. Percent reduction of wound surface area, on Day 8, 15 and 22 from Day 1.
    4. Incidence of treatment failure defined as less than 30% decrease in wound size after 22 days treatment.
    5. Incidence of eligibility to skin transplantation after treatment of Kék Lukács ointment if needed.
    6. To assess the ease of application of Kék Lukács ointment; evaluating pain at application and at dressing changes at every visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 22
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state44
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After treatment period patients will be followed up for Day 57, controlled at Day 28 ± 3 and at Day 57 ± 3.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-10-31
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